Director – Human Factors
Company | AstraZeneca |
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Location | Boston, MA, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | Bachelor’s |
Experience Level | Expert or higher |
Requirements
- Degree in human factors engineering, mechanical engineering, bioengineering or related field is required
- 10+ years’ experience in combination product or medical device development
- At least 7 years focused on human factors engineering (HFE)
- Strong depth of knowledge in Human Factors engineering including a working knowledge of US/EU guidances and standards related to human factors/usability, design controls and risk management
- Strong communication skills with an ability to influence internal partners as well as external industry and health authorities
- Ability to lead a global team, create a positive work environment and effectively develop staff
Responsibilities
- Lead Human Factors efforts for combination product and new technology development including ethnography, requirements definition research, formative studies, instruction and training development, risk analysis and summative studies
- Write and review HF sections for health authority submissions
- Interact with health authorities during face to face meetings and in written responses
- Engage AstraZeneca senior leaders in development, quality, regulatory, clinical, commercial and operations with regards to HF strategy, implementation and standard processes
- Manage HF engineers and mentor the group professionally
- Be a voice of user centricity across all product types in AstraZeneca
- Be engaged with and influence Human Factors standard processes externally across industry and with regulators
- Improving internal Human Factors processes to ensure consistency, compliance and efficiency
Preferred Qualifications
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No preferred qualifications provided.